Head/DGM/AGM/Senior Manager - Regulatory Affairs/QA/QC (10-20 yrs)
JD for Regulatory Affairs :
Regulatory Head for US Market :
Role : RA Head for US market
Designation : DGM/AGM/Senior Manager
Experience : 15-20 Years in Regulatory Affairs plus QA/QC experience
Candidates preferably from Injectables / Parentrals Background
Education : Any UG /PG
Reporting : Directly to Managing Director
Job Location : Hosur Location
Roles and Responsibilities :
- Build and nurture a team for US focussed regulatory
- Manage new submissions of ANDAs
- Mentor and provide guidance to cross functional team on regulatory requirement for products
- Train the cross functional team on regulatory updates
- Act as program manager and work with customers to ensure timely and smooth filing.
- Assist the customer for product launch in the US market.
- Management of Post Approval Supplements: CBE, CBE-30, Prior Approval Supplements, Annual reports, Site Transfers etc.
- Management of Deficiencies: Telephone, Minor, Major CMC Amendments in compliance to the queries from US FDA
NOTE : If above position is suitable to you, please contact me & share your profile
Keyskills : RA QA Regulatory Affairs US Market Senior Management
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